1.1. Pharmacists’ contribution to greater safety of new therapies, such as cell and genetic therapies

At present most gene therapies are based on experimental research carried out in laboratories. For clinical applications, medicines must comply with GMP, GCP and bio-safety criteria. Pharmacists are experts in this field.

The pharmacist is a broadly educated health professional with a solid grounding in basic science. However, in the initial curriculum, special emphasis should be placed on new developments in biology.

There has to be additional specialisation within each pharmacy discipline, such as hospital pharmacy and community pharmacy. Nevertheless a common core of basic concepts in these new therapies should be included in basic and further training for every pharmacist.

With regard to new treatments and their usually very early launch on the market, it is essential to carry out post-marketing monitoring including verification and documentation of the therapeutic protocols. Pharmacists should perform this task in order to guarantee the quality of the treatment.

Quality management of therapy processes (TQM = total quality management) must be a compulsory topic in pharmacy training. Such management must be carried out by an inter-disciplinary team.

Knowledge of pharmaco-economics and pharmaco-epidemiology is essential if pharmacists are to be part of interdisciplinary teams (outcome evaluation).

Because of the high costs and potential risks of these therapies, rules on access to those treatments have to be set. Such treatment must be subject to health authority control. The extent of insurance coverage has to be taken into account.

Community pharmacists involved in the long-term care of patients undergoing such treatment need to have been given the appropriate training and be specialised in this field. Community pharmacists have to be linked with the hospital team and with the home care team.

Pharmacotherapeutic risk was considered in the context of adverse drug reactions, medication errors, poor compliance, drug interactions/incompatibilities and quality of medicines, including formulation. In one of the workshops a semantic and cultural debate occurred between three terminologies - iatrogenic effects, medication errors and ADRs. An important misunderstanding was evident between the effects of drugs, including adverse reactions linked to the molecule, and medication errors. Two perspectives were presented - the observer (health professional) perspective and the patient perspective.

The consequences for the patient and society of not managing the therapeutic risks are seen for example in increased morbidity, increased mortality, increased litigation and increased cost. The key objectives of therapeutic risk management are to therefore obtain optimal safety, optimal efficacy and optimal integrity of the medication.

At the strategic level risk management was seen in terms of drug policy formulation, the establishment of protocols/procedures for medication use and control, and formal regulatory control.

At the individual patient care level, risk management by the pharmacist was viewed in terms of contribution within a medication management framework, involving doctors, patients , their carers and other health care professionals. Thus, it was in the context of a team approach where the pharmacist brought unique knowledge and expertise Specific areas of pharmaceutical contribution include:

TDM;
individualised therapy within the pharmaceutical care concept;
health promotion/disease prevention;
information on the medication decision-making process;
choosing a specific medication from a broader therapeutic category indicated by the prescribing doctor;
assuming a patient advocate role;
assessing patient medication;
education of prescribers, patients and other health and social care professionals.

The communication role of the pharmacist was emphasised and the necessity to show empathy, particularly for patient interviews and in the provision of patient information, both oral and written. Different experiences were described in respect of identification and evaluation of medication errors in the US and in France (a study in 990 community pharmacies). The importance of prescription control and establishing a patient medication record, including clinical information, was emphasised. The need for easy to identify patient packs, in preference to unit dose, with proper patient information leaflets was advocated in community pharmacy.

In overall terms this would mean the pharmacist taking responsibility for and managing patients' medication, in consultation with prescribers and patients.

Alongside this personal contribution, it is necessary to use other appropriate therapeutic tools, such as bar coding to give a therapeutic audit trail, ADR databases and patient profiles/medication records.

Demonstrating and quantifying the risk management need is a key first step in any given context. This will determine the mechanisms needed to be applied, as well as the baseline on which performance/outcomes can be evaluated. Implementation will also provide the subsequent factual base for future pharmacist-led risk management services.

The pharmacist must perform the role of quality assurance manager for the therapeutic risk management system, and be recognised as the accredited person.

1.3. COUNTERFEIT MEDICINES – REDUCING THE RISKS

PREAMBLE

The counterfeiting of medicines has been discussed in documents produced by WHO, IFP, and good manufacturing guidelines issued by the European Union. These documents should be updated regularly. It is important that all countries enforce these regulations. It is also important to reinforce contacts and information exchanges between all partners and states.

Dr Dietrich Schnädelbach’s paper highlighted the major issues at stake and the various levels on which action could be taken, i.e. by industrial producers, wholesalers/distributors, community pharmacists and public health authorities.

More specifically, the Working Groups think that the following points should be emphasised:

Industry

Official producers should be urged to devise sealed packaging, carrying a distinctive mark, like the metallic thread in banknotes, which would facilitate the rapid detection of counterfeit products circulating on the market.

Manufacturers affected by counterfeiting should be persuaded to take systematic legal action against all offenders.

Wholesalers/distributors

Medicines of dubious origin might be subjected to additional checks of the kind carried out in Belgium by the SCM (the Pharmaceutical Association's medicines control department).

Quality controllers should supervise all stages of the distribution process.

Community pharmacists

Community pharmacists and users should be made more aware of the existence of counterfeit products, of their liabilities and of the potential risks involved.

Community pharmacists can best avoid counterfeit products by choosing their suppliers carefully.

Governments

Producers should be subject to more stringent inspection, if necessary by inspectors specialising in the punishment of offenders, essentially for the purpose of ensuring that products are more easily traceable and of validating documents.

Care should be taken not to push open market and low price policies to extremes, since this may result in counterfeiting (for example, parallel imports).

Intergovernmental organisations should be encouraged to help officials working in developing countries to pursue clear-sighted policies for the benefit of their communities.

The authorities should be encouraged to take more vigorous action against unsupervised import, distribution, and marketing circuits.

1.4.a. SELF-MEDICATION: THE ADDED VALUE OF THE PHARMACIST

Definition

The terms "assisted medication" and "community medication" are preferable to the term "self-medication"; they better reflect the vital role of the pharmacist as an adviser on health safety.

Pharmacists’ income is dependent on the volume and price of medicines sold

Accountability

Pharmacists are responsible for everything they dispense.

Their advice is vital to health safety.

It is the accountability of a health care professional that gives pharmacists their credibility.

Proposed action

Criteria for assessing the complaint and advising customers should be set

The image of the pharmacist as a "family pharmacist" must be promoted to the public, other care providers and the health authorities.

WORKSHOP CONCLUSIONS
SECOND DAY (Thursday 21 October 1999)

2.1. Facing up to the problem of Internet sales of medicines

Countries vary largely in their regulations on the sale of medicinal products via the Internet, e.g. the different approach to the distinction between prescription medicines and OTC products. Effective control of trade over the Internet is difficult, and the problem is exacerbated by the abolition of borders within the European Union. The small size and “innocent” appearance of parcels makes it virtually impossible for customs officers to detect that they contain pharmaceuticals. It was agreed that the distribution chain is not effectively controlled; in certain countries wholesalers play an important role. It is difficult to hold manufacturers responsible if official distribution channels are bypassed. Consignments of pharmaceutical products may be stolen, products may be counterfeited. There was severe condemnation for the actual practice of doctors prescribing a medicine on the basis of data provided by the patient over the Internet.

sales of certain illegal medicines and products presented as medicines but which have not been approved
lack of personal counselling by the health-care professional
unknown liability
misleading advertising
security of transactions
transportation conditions (particular requirements for certain medicines)

Informing consumers is of vital importance, but it is sometimes difficult to distinguish where information ends and promotion begins.

It was unanimously agreed that pharmacists play an important role in informing the public.

Recommendations

There is a need for good distribution practices which should be developed in an international context.
Advertising regulations should be harmonised at international level.
Contrary to the current text of the draft European guideline on E-commerce, the regulations of the target country should apply, not those of the country of origin.
In all countries, wholesalers should be specifically authorised, their duties specified.
The problem of Internet and the liability of originating and target countries should be looked at in the World Trade Organisation.
Legislation regulating Internet sales of pharmaceuticals should be developed and strongly enforced.
Comprehensive information campaigns should be started through concerted action by relevant parties, including governments, professional organisations, consumer organisations, the pharmaceutical industry and community pharmacists.
Trustworthy websites containing reliable information should be identified and made recognisable as such for the consumer.
There should be websites of non-profit making organisations referring consumers to local pharmacies.
A rigid control system for legal on-line pharmacies should be established at world level.
Where possible, there should be tight control over the owners of websites.

2.2. PHARMACISTS AS PART OF PROFESSIONAL NETWORKS: WHAT ARE THE ISSUES?

Definition

A network is defined by different criteria :
discipline or skills of its members (same profession or different profession),
goals (information, product flow chart, further training, patient care etc),
areas (regional, national, international, etc)

Different networks exist in the different countries.

Evolution

We are sure that the networks will develop;
We want them to develop;
We want networks to be created in the interest of the patients.

The networks will involve all or sometimes only some of the pharmacists.

Tools

Internet/Intranet
Telematics
Smart cards

Confidentiality of data

Patient-oriented data must be confidential and must not be used for commercial purposes.
Only part of the data could be transferred to another member of the network.

Pharmacists

must play an active role,
must enable other health-care professionals to benefit from their skills,
must collaborate but remain independent,
must have certain qualities (attitude, willingness to collaborate),
must comply with legal provisions when operating in the network,
must be trained for this activity,
must prove the benefits of pharmaceutical added value.

Requirements

Defining quality and security criteria for the networks,

Taking care with the development of collaboration not directly in the interest of the patient.

Partners

What are our partners’ expectations of the pharmacist? (e.g. what do doctors expect?)

Co-operation between pharmacists and practitioners:

Good co-operation at local level

Co-operation at top level should be improved.

There should be co-operation between the hospital sector and the non-hospital sector.

Obstacles to co-operation

Different legal responsibilities
Different economic responsibilities.

Means of overcoming the obstacles

Increase interaction

Among professional organisations
At local level between pharmacists and other practitioners
At the level of training
Via joint projects

2.3. RESOLVING PROBLEMS RELATED TO THE ELECTRONIC TRANSMISSION OF PRESCRIPTIONS

With the exception of the Netherlands and the United Kingdom, there is no experience of electronic transfer of prescriptions. Both of those countries have experimented with the use of Intranet but not with the Internet.

Problems to be solved

Regulations

Data protection act
Electronic signatures, not yet recognised in most systems of domestic legislation
Patients’ freedom of choice
Patients’ control of information concerning them

Responsibility

In a paperless system, what is the definition of the original document?
Who is responsible when the system fails, when messages are lost, etc?
Who oversees the system?

Security

Entry by PIN, password or smart card
Different access levels depending on the purpose
to write prescriptions
to dispense prescriptions
to gather data in an anonymous form
All access is on a “need to know” basis
The larger the intranet the less secure it will be
Need for data backups if using a card system in case of loss
Identification of cardholder and messages sent

Professionals will receive more accurate information in real time
In certain circumstances, patients could receive a better service
It might prove difficult to convince the patient of the immediate benefit
If this concept is to be effective, systems must be introduced throughout the chosen geographical area at the same time.

2.4. HOW SHOULD PHARMACISTS TAKE ADVANTAGE OF THE POTENTIAL OF NEW INFORMATION TECHNOLOGIES FOR THE BENEFIT OF THE PATIENT?

Preamble

The main issue concerning the design of any datasheets for IT systems in healthcare should be the potential benefits to both public health and individual patient care.

There may be barriers to the use of IT in healthcare including:
Professional conflicts e.g. between physicians and pharmacists
The lack of real evaluation of IT systems
The need for education to implement any system
The funding required for developing and supporting IT systems.

However, these barriers can be reduced and overcome if pharmacists and other healthcare professionals can demonstrate the benefits of shared IT systems to their patients and can build on their trust and loyalty.

Cultural and national differences may be important in the development of healthcare IT systems. Two examples involving pharmacies linked to a central system were quoted, specifically the Netherlands and British Columbia, other countries were more sceptical of this approach. This may be because system developments were driven by health insurance company needs, rather than patient needs and professional practice.

Proposals

Applying a recognised label of validity to all the data accessible via Internet to date and not yet validated, with a view to putting some order in the information circulating in the pharmacotherapy field and ensuring that such information is continuously monitored and assessed. Ultimately, what should be achieved is a European site set up under the auspices of the Council of Europe.

Providing support for the development of cyber-pharmacies, where patients can obtain information as and when they require, using data validated by the community pharmacist on the basis of approved (labelled) sites.

Standardising therapeutic indications within the framework of product licence files throughout Europe, to achieve true harmonisation of the information provided to the patient.

Setting up specialised sites for professionals and also standardised information systems comprehensible for the patient, which are either installed on the server network under the moral responsibility of European structures or produced in the form of CD-ROMs.

Developing the new information technologies for the purposes of further pharmaceutical training, in that the prime objective of further training of health care professionals must be to improve the quality of care dispensed to the patient. The Council of Europe could support a project to pool existing IT developments. This might lead to the establishment of European post-graduate training programmes.

Developing the new information technologies for the purposes of producing a pharmaceutical dossier with cross-referenced medical, biological and pharmaceutical data permitting a global assessment of the patient's pharmacotherapy status. This dossier would duly respect the patient's confidentiality and rights and would be governed by the principle of shared professional secrecy, serving as a tool for individual treatment policy. It would improve patient monitoring between towns, between town and hospital and even between hospitals.

Finally, in the context of student specialisation, the group proposes that pharmacy faculties could provide multidisciplinary training in the new information technologies in order to improve patient care and reduce professional conflict.

Conclusions

The need to establish the strategy for improving pharmacotherapy and then exploring how IT can enable this goal to be realised.

In many countries there are developed IT systems for drug interaction monitoring or alerts. Looking to the future, other IT systems are needed to support pharmaceutical care and disease management. Common datasheets across Europe need to be identified.

If patients and consumers recognise the benefits from pharmacists accessing patient profiles, patients will support pharmacists and other health professionals in making the case for funding of IT systems.